Clinical research studyTumor Necrosis Factor Antagonist Responsiveness in a United States Rheumatoid Arthritis Cohort
Section snippets
Materials and Methods
Patients with a diagnosis of rheumatoid arthritis and no previous biologic agent use who were enrolled in the registry and prescribed a TNF antagonist for the first time were included. The study period was from March of 2002 to May of 2006. The Consortium of Rheumatology Researchers of North America registry is a prospective observational study of patients with arthritis who were enrolled by participating rheumatologists at both academic and private practice sites; the details have been
Patient and Baseline Disease Activity Characteristics
Baseline characteristics and disease activity levels of patients in cohorts A and B are summarized and compared in Table 1, showing no significant differences with the exception that patients in cohort A were less frequently rheumatoid factor positive (69.8% vs 82.8%, P = .016). Similar proportions of patients prescribed TNF antagonists in cohorts A (27.9%) and B (28.4%) had high Clinical Disease Activity Index scores at baseline. The proportion of patients in cohort A with low, moderate, and
Discussion
In this multicentered US-based cohort study of patients with rheumatoid arthritis who were prescribed TNF antagonists, we had 2 principal findings. First, we observed that less than one fifth of patients with rheumatoid arthritis in the study cohorts prescribed a TNF antagonist would have met the eligibility requirements from 3 major TNF antagonist trials, primarily because of disease activity requirements. The proportion of patients with rheumatoid arthritis satisfying requirements for trial
Conclusions
This study of a large US cohort with rheumatoid arthritis indicates that less than one fifth of patients prescribed TNF antagonists meet typical eligibility requirements from TNF antagonist trials, and that patients failing to meet these criteria achieve inferior responses. These findings highlight the tradeoff between defining a treatment-responsive population and generalizing data from randomized controlled trials to the larger population of patients with rheumatoid arthritis who are treated
Acknowledgment
Dr. Greenberg was supported by Grant Number K23AR054412 from the National Institute of Arthritis And Musculoskeletal And Skin Diseases and a Clinical Translational Research Award in Rheumatoid Arthritis from the Arthritis Foundation. Dr. Greenberg serves as Chief Scientific Officer for CORRONA.
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Tools and Methods for Real-World Evidence Generation: Pragmatic Trials, Electronic Consent, and Data Linkages
2019, Rheumatic Disease Clinics of North AmericaCitation Excerpt :The hoped-for benefits of generating evidence and obtaining it from routine care settings, as may be recorded in electronic medical record (EMR) systems, administrative claims data (eg, pharmacy refill data), mobile health, and other diverse sources, is not only to improve the generalizability of research but also to expand the available evidence for patients with significant disease heterogeneity, multimorbidity, and more severe disease manifestations than typically permitted in an RCT. For example, the proportion of rheumatoid arthritis (RA) patients seen in routine care settings who would be eligible for a typical phase 3 RCT has been estimated to be 20% or even lower.2,3 Additional factors that may affect clinical outcomes that would be irrelevant, or considered nuisance factors in an RCT, can also be studied more effectively using real-world data.
Comparison of Anti-TNF Treatment Initiation in Rheumatoid Arthritis Databases Demonstrates Wide Country Variability in Patient Parameters at Initiation of Anti-TNF Therapy
2011, Seminars in Arthritis and RheumatismCitation Excerpt :Characteristics of OH patients were compared with those of RA patients in the OBRI and REACH registries and in published American, Czech, British, Dutch, Danish, Norwegian, Swedish, Finnish, Italian, German, Spanish and Australian databases. The databases were the Consortium of Rheumatology Researchers of North America (CORRONA) (6), National Data Bank for Rheumatic Diseases (NDB) (12), Czech National Registry (13), British Society for Rheumatology Biologics Registry (BSRBR) (14), Dutch Rheumatoid Arthritis Monitoring (DREAM) (15), Danish Registry of Biological Therapies (DANBIO) (16), Norwegian Disease Modifying Anti-Rheumatic Drug (NOR-DMARD) (17), Anti-Rheumatic Therapies in Sweden (ARTIS) (18), South Swedish Arthritis Treatment Group (SSATG) (19), The Register of Biological Treatment in Finland (ROB-FIN) (20), Lombardy Rheumatology Network registry (LORHEN) (21), German Rheumatoid Arthritis Observation of Biologic Therapy (RABBIT) (22), Spanish Registry of Adverse Events of Biological Therapies in Rheumatic Diseases (BIOBADASER) (23), and Australian Rheumatology Association (ARAD) (24) databases. The NDB and CORRONA registries contained data from American patients only.
Outcome and safety of TNFα antagonist therapy in 475 consecutive outpatients (with rheumatoid arthritis or spondyloarthropathies) treated by a single physician according to their eligibility for clinical trials
2010, Joint Bone SpineCitation Excerpt :A study in RA patients in The Netherlands [3] found that 56% of patients on average did not meet trial selection criteria, in keeping with our results. Higher rates were noted in the German RABBIT registry (67 to 79%) [29] and in the US (80%) [4]. Another limitation of our study is the subjective evaluation of effectiveness using four response categories.
A Comparison of Patient Characteristics and Outcomes in Selected European and U.S. Rheumatoid Arthritis Registries<sup>1</sup>
2010, Seminars in Arthritis and RheumatismCitation Excerpt :Comparable data were available for RABBIT, CORRONA and VARA. Only between 6 and 33% of patients in RABBIT, CORRONA and VARA would have been eligible for the clinical trials that were reported in common (17,18). Among patients who were eligible for these trials, ACR20 and ACR50 responses were comparable between the observational cohorts (RABBIT and CORRONA) and the respective clinical trials.
Dr Greenberg was supported by grant number K23AR054412 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and a Clinical Translational Research Award in Rheumatoid Arthritis from the Arthritis Foundation. Dr Kishimoto was funded by a fellowship grant from the Consortium of Rheumatology Researchers of North America.